Sling assembly with secure and convenient attachment

ABSTRACT

Surgical articles that are conveniently and securely coupled are disclosed. Improved surgical procedures are also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application is a continuation-in-part of U.S. patentapplication Ser. No. 10/005,837 filed Nov. 9, 2001 (Attorney Docket No.AMS-029) and U.S. patent application Ser. No. 09/917,443 filed Jul. 27,2001 and U.S. patent application Ser. No. 09/917,562 filed Jul. 27, 2001and claims priority thereto and of U.S. Provisional Application SerialNo. 60/263,472, filed Jan. 23, 2001; and U.S. Provisional ApplicationSerial No. 60/269,829, filed Feb. 20, 2001, and U.S. ProvisionalApplication Serial No. 60/281,350, filed Apr. 4, 2001; and U.S.Provisional Application Serial No. 60/295,068, filed Jun. 1, 2001, andU.S. Provisional Application No. 60/306,915, filed Jul. 20, 2001, andU.S. Provisional Patent Application Attorney Docket No. AMS-032P, filedNov. 20, 2001, entitled, “Sling Assembly Articles” (all of whosecontents are fully incorporated herein by reference).

BACKGROUND

[0002] Urinary incontinence is a significant health concern worldwide.Incontinence may occur when the pelvic floor weakens. There are fivebasic types of incontinence: stress incontinence, urge incontinence,mixed incontinence, overflow incontinence and functional incontinence.There are a large number of surgical interventions and procedures foraddressing incontinence.

[0003] Some surgeons are slow to adopt promising new surgical techniquesfor treating incontinence for a variety of reasons. Some are simplyunwilling to try new instrumentation that seems unfamiliar. Others mayfind new instrumentation inconvenient or awkward.

[0004] A variety of surgical procedure options are currently availableto treat incontinence. Depending on age, medical condition, and personalpreference, surgical procedures can be used to completely restorecontinence. One type of procedure, found to be an especially successfultreatment option for SUI in both men and women, is a sling procedure.

[0005] A sling procedure is a surgical method involving the placement ofa sling to stabilize or support the bladder neck or urethra. There are avariety of different sling procedures. Descriptions of different slingprocedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515;5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.

[0006] Sling procedures differ in the type of material used for thesling, the method of anchoring the sling material in the body and howthe sling material is inserted in the body. The time required for asurgical procedure varies, but is preferably as short as possible. Thisfactor is frequently reported in urology and gynecology literature. SeeAtherton M. J., et al., A Comparison of Bladder Neck Movement andElevation After Tension-free Vaginal Tape and Colposuspension, BritishJournal of Obstetrics and Gynaecology, November 2000, Vol. 17, p.1366-1370, Nilsson et al, The Tension-free Vaginal Tape Procedure isSuccessful in the Majority of Women with Indications for SurgicalTreatment of Urinary Stress Incontinence, British Journal of Obstetricsand Gynaecology, April 2001, Vol. 108, P. 414-419; and Ulmsten et al.,An Ambulatory Surgical Procedure Under Local Anesthesia For Treatment ofFemale Urinary Incontinence, Int. Urogynecol. J. (1996), v. 7, pps.81-86.

[0007] Although serious complications associated with sling proceduresare infrequent, they do occur. Complications include urethralobstruction, development of de novo urge incontinence, hemorrhage,prolonged urinary retention, infection, and damage to surrounding tissueand sling erosion.

[0008] The Tension-free Vaginal Tape (TVT) procedure (available fromEthicon, of N.J.) utilizes a Prolene™ nonabsorbable, polypropylene mesh.The mesh is a substantially flat, rectangular knitted article. The meshincludes a plurality of holes that are sized to allow tissue ingrowth tohelp avoid infection. A plastic sheath surrounds the mesh and is used toinsert the mesh. During the sling procedure, incisions are made in theabdominal (i.e. suprapubic) area and in the vaginal wall. Two curved,relatively large (5 mm or larger) needle-like elements are eachconnected to an end of the vaginal sling mesh. A sling-free, sharp tipend of one of the needle-like elements is initially pushed through thevaginal incision and into the paraurethral space. Using a handleattached to the needle, the needle is angulated laterally (for example,to the right) to perforate the endopelvic fascia, pushed through theretropubic space and passed through the abdominal incision. The handleis disconnected and the needle is then withdrawn through the abdominalwall, thereby threading a portion of the sling through the tissue of thepatient. The handle is then connected to the other needle and thetechnique is repeated on the contralateral side, so that the mesh islooped beneath the bladder neck or urethra. The sling is positioned toprovide appropriate support to the bladder neck or urethra. At the endof the procedure, the sling ends are cut at the abdominal wall, thesheath is removed and all incisions are closed.

[0009] Complications associated with the TVT procedure and other knownsling procedures include injury to blood vessels of the pelvic sidewalland abdominal wall, hematomas, urinary retention, and bladder and bowelinjury due to passage of large needles. One serious disadvantage of theTVT procedure, particularly for surgeons unfamiliar with the surgicalmethod, is the lack of information concerning the precise location ofthe needle tip relative to adjacent pelvic anatomy. A cadaver study hasindicated that the TVT needle is placed in close proximity to sensitivetissue such as superficial epigastric vessels, inferior epigastricvessels, the external iliac vessel and the obturator. See, Walters, MarkD., Percutaneous Suburethral Slings: State of the Art, presented at theconference of the American Urogynecologic Society, Chicago (October2001).

[0010] If the TVT needle tip is allowed to accidentally pass across thesurface of any blood vessel, lymphatic duct, nerve, nerve bundle ororgan, serious complications can arise. These shortcomings, attempts toaddress these shortcomings and other problems associated with the TVTprocedure are disclosed in PCT publication nos. PCT WO 00/74633, PCT WO00/74613 and PCT WO 00/74594.

[0011] Additional problems are associated with the TVT procedure.Removal and reuse of the handle of the TVT product is a cumbersome, timeconsuming process, requiring the surgeon to manually rotate the handleuntil the handle is unscrewed from the needle. Reusing the handlepresents a contamination risk, particularly if the handle and screwthreads are not properly cleaned and sterilized after use on thepatient.

BRIEF SUMMARY

[0012] The present invention includes surgical instruments, articles andprocedures for urological applications, particularly incontinencesurgical procedures.

[0013] In one aspect, the present invention comprises a surgicalassembly for treating incontinence. The assembly comprises an elongateneedle, a sling and a coupler. The needle is sized and shaped to beinitially inserted through an abdominal incision and to then emerge froma vaginal incision. The needle has an insertion end and an end oppositethe insertion end. The insertion end of the needle is preferably blunt.The sling is constructed of a material that is capable of beingimplanted during the incontinence procedure.

[0014] The coupler has an elongate body with an axis. The body has afirst end and a second end with surfaces for conveniently and securelyconnecting the coupler to the insertion end of the needle by moving thecoupler and insertion end of the needle together in a substantiallyaxial fashion.

[0015] The coupler is convenient and easy to connect to the needle.Preferably, the assembly has an Insertion Force (described in greaterdetail below) of no more than about fifteen pounds. More preferably, theInsertion Force is no more than about ten pounds. Even more preferably,the assembly has an Insertion Force of no more than about eight pounds.

[0016] Once the coupler and needle are connected, they should notseparate, especially within the body. Preferably, after the needle isconnected to the coupler, the assembly has a Separation Force (describedin greater detail below) of at least about fifteen pounds, morepreferably of at least about thirty pounds.

[0017] In another aspect, the present invention comprises the couplerdescribed above. The first end of the coupler connects to a firstneedle. The second end of the coupler can be associated with a sling,insertion sheath or both.

[0018] Optionally, the coupler can comprise a needle adapter forconnecting a first needle to a second needle. In this embodiment, thesecond end of the coupler receives an end of a second needle so that thecoupler and first needle may guide the second needle through the body.

[0019] In another aspect, the present invention comprises an improvedmethod of treating incontinence in a female patient. The methodcomprises the steps of: i) providing a surgical mesh, and a removablesynthetic insertion sheath, ii) providing a needle that is sized andshaped to be initially inserted through a suprapubic incision and tothen emerge from a vaginal incision, iii) providing a coupler having anaxis, the coupler having a first end and a second end with surfaces forconveniently and securely connecting the coupler to an insertion end ofthe needle, iv) creating at least one vaginal incision, v) creating atleast one suprapubic incision, vi) passing the leading end of the needleinitially through the suprapubic incision and then through the vaginalincision, vii) then connecting the coupler to the needle by moving thecoupler and insertion end of the needle together while the insertion endof the needle protrudes from the vaginal incision, viii) implanting thesling by moving the leading end of the needle from the vaginal incisiontoward the suprapubic incision, and ix) then removing the syntheticinsertion sheath.

[0020] Preferably, the step of connecting the coupler to the needle bymoving the coupler and insertion end of the needle together includes thestep of: pushing the coupler onto the insertion end of the needle in asubstantially axial fashion.

[0021] In another aspect, the present invention comprises an improvedsurgical method including the steps of i) providing a first needle thatis sized and shaped to be initially inserted through an abdominalincision and to then emerge from a vaginal incision, the needle havingan insertion end and an end opposite the insertion end, ii) providing acoupler having an axis, the coupler having a first end and a second endwith surfaces for conveniently and securely connecting the coupler tothe insertion end of the needle, iii) providing a second needle that issized and shaped to be initially inserted through a vaginal incision andto then emerge from an abdominal incision; the second needle beingattached to a synthetic surgical mesh, and a removable syntheticinsertion sheath, iv) creating at least one vaginal incision, v)creating at least one abdominal incision, vi) initially passing thefirst needle through the abdominal incision and then through the vaginalincision, vii) connecting the second end of the coupler to the insertionend of the first needle, viii) connecting the first end of the couplerto the second needle; and ix) guiding the second needle from the vaginalincision to the abdominal incision with the first needle to implant thesling.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Other features and advantages of the present invention will beseen as the following description of particular embodiments progressesin conjunction with the drawings, in which:

[0023]FIG. 1 is a perspective view of one embodiment of assemblyaccording to the present invention;

[0024]FIG. 2 is a perspective view of a coupler according to the presentinvention,

[0025]FIG. 3 is a top view of the coupler shown in FIG. 2;

[0026]FIG. 4 is a side view of the coupler of FIG. 2;

[0027]FIG. 5 is top view of the coupler shown in FIG. 2, similar to theview shown in FIG. 3, but showing different reference characters;

[0028]FIG. 6 is a sectional view of the coupler of FIG. 5;

[0029]FIG. 7 is a side view of a coupler associated with a sling or asling assembly;

[0030]FIG. 8 is a sectional view of the coupler shown in FIG. 2, similarto the view shown in FIG. 6, but showing different reference characters;

[0031]FIG. 9 is a perspective view of a needle according to the presentinvention;

[0032]FIG. 10 is an end view of a needle according to the presentinvention;

[0033]FIGS. 11 and 12 are side schematic views wherein:

[0034]FIG. 11 shows a needle being inserted into a coupler according toan Insertion Force Test; and

[0035]FIG. 12 shows a needle attached to the coupler and a SeparationForce Test according to the present invention;

[0036]FIGS. 13 through 17 are perspective views sequentially showing theinsertion of a needle suprapubically in accordance with one aspect ofthe present invention, wherein:

[0037]FIG. 13 shows the needle just passing an abdominal incision;

[0038]FIG. 14 illustrates the needle as the surgeon seeks to identifythe tactile feel of the resistance provided in part by the posteriorportion of the pubic bone;

[0039]FIG. 15 shows the needle as it passes along the posterior surfaceof the pubic bone which may be used as an anatomical guide for a surgeonas the needle approaches a vaginal incision;

[0040]FIG. 16 illustrates the needle as it passes out of a vaginalincision;

[0041]FIG. 17 is a perspective view of a sling attached to two needlesaccording to an embodiment of the present invention;

[0042]FIG. 18 is a perspective view of a sling being pulled upward inaccordance with the present invention,

[0043]FIG. 19 is a perspective view of the sling according to thepresent invention after the couplers have been separated from the restof the assembly, but prior to final trimming;

[0044]FIG. 20 is a perspective view of the sling according to thepresent invention after the sheath has been removed and the sling hasbeen trimmed; and

[0045]FIG. 21 is a perspective view of a first needle after it has beeninserted suprapubically and emerges from a vaginal incision, a couplerconnected to the first needle after the needle has been insertedsuprapubically, and a second needle for implanting a sling that isassociated with the other end of the coupler in preparation for beingmoved through the patient.

DETAILED DESCRIPTION

[0046] The following description is meant to be illustrative only andnot limiting. Other embodiments of this invention will be apparent tothose of ordinary skill in the art in view of this description.

[0047] The present invention is directed to surgical instruments, andimplantable articles for treating medical disorders such as incontinenceor stress urinary incontinence (SUI) in both men and women. The presentinvention is also directed to improved surgical procedures that utilizethe surgical articles. Although the invention as disclosed hereingenerally refers to SUI, treatment of other urological disorders, suchas urge incontinence, fecal incontinence, mixed incontinence, overflowincontinence, functional incontinence, prolapse (e.g. vaginal anduterine), enteroceles (e.g. of the uterus or small bowel), rectoceles,cystoceles and other disorders are also included within the scope of thepresent invention. It is contemplated that the present invention mayalso be utilized in conjunction with concomitant procedures, such as,but not limited to, procedures for addressing cystocele, rectocele,vaginal prolapse and anatomic corrections.

[0048] In one aspect, the present invention comprises an assembly 40 foruse in surgery. FIG. 1 illustrates a sling 42, a needle 60 and a dilatoror coupler 54.

[0049] The needle 60 is preferably sized and shaped to pass initiallythrough an abdominal incision and then emerge through a vaginalincision. Typically, the needle will have an elongate body and a pair ofends 58 and 62.

[0050]FIG. 9 illustrates a curved needle 60. The needle 60 is preferablyarc-shaped and includes end 58 and end 62. The ends or tip of the needle60 are preferably not sharp, but may be tapered to afford easy passagethrough tissue while providing a blunt surface that avoids cuttingsensitive tissue such as the bladder or urethra. In a preferredembodiment, the length of the needle 60 is approximately within therange of 16.5 cm to 24.1 cm (6.5 inches to 9.5 inches) and has apreferred external diameter of approximately 3.175 mm (0.125 inch).Preferably, the diameter of the needle 60 is small to reduce tissuetrauma and increase control.

[0051] The needle 60 is preferably made of a malleable, yet durable,biocompatable surgical instrument material such as, but not limited to,stainless steel (e.g. 316 stainless steel or 17-4 stainless steel),titanium, Nitinol, polymers, plastics and other materials, includingcombinations of materials. The needle 60 should have sufficientstructural integrity to withstand the various forces (e.g. forces causedby coupler attachment, and penetration/passage of the needle 60 throughthe various tissues) without undergoing any significant structuraldeformation. Optionally, the needles 60 could be sufficiently malleableto allow a practitioner or user of the device to modify the needle 60 toa desired shape and, thereby, optimize the procedural approach.

[0052] In another aspect of the present invention, different types ofneedles may be provided that need not serve the same purpose in asurgical procedure. FIG. 21 illustrates a suprapubic needle 602 (e.g.with a preferred diameter of about 4 mm, or less, more preferably about3 mm) and a relatively larger sling associated needle 604 (e.g. with adiameter of 5 mm). Preferably, the sling associated needle has a slingassembly 610 (e.g. a sling mesh and insertion sheath) attached thereto.

[0053] The suprapubic needle 602 serves a different purpose than thesling associated needle 604. The suprapubic needle 602 is preferablysmall and has a blunt tip. The blunt tip is initially inserted throughan abdominal or suprapubic incision 400 and then through a vaginalincision 404. Inserting a small, blunt needle in this fashion providesthe surgeon with addition control in maneuvering through the anatomy ofa patent and in avoiding sensitive tissue.

[0054] A surgical assembly according to an aspect of the presentinvention may include a coupler 54 adapted to be snapped onto the end ofneedle 602. The sling associated needle 604 may optionally include asharp tip. The coupler receives the tip or end of the needle 604.Pushing upward on the sling associated needle 604 (e.g. with one hand)while optionally steering or guiding the tip of the needle 604 byholding needle 602 (e.g. with the other hand) is believed to providebetter control over insertion of a prior art large needle that isinitially inserted through the vaginal incision 404 and then through thesuprapubic incision.

[0055] Alternatively, the coupler and/or needle 604 can include surfacesfor firm engagement and attachment between coupler and needle 604. Thosesurfaces can include mechanical interlocking structures, graspingstructures or interference structures. Optionally, a biocompatibleadhesive may be used to adhere the tip of sling associated needle 604 tothe coupler/adapter.

[0056] Referring again to FIG. 1, the assembly includes a sling material42 (e.g. as part of the sling assembly 46). As used herein, the terms“sling” or “article” or “mesh” or the phrases “implantable material” or“implantable article” or “sling mesh” (or combinations thereof) are usedgenerally to describe a variety of materials including synthetic andnon-synthetic materials. Typically, the implantable article will beelongate and substantially flat. It can be used as a hammock, sling,strip or support member. Optionally, the sling 42 can include a slingtensioning member 66 (e.g. as disclosed in U.S. patent application Ser.No. 09/917,562, filed Jul. 27, 2001).

[0057] While the sling 42 is preferably rectangular for treating SUI infemales, other shapes are also contemplated. Depending on the treatmentaddressed (e.g. to provide hammock support for the bladder or bladderneck, or to address a rectocele, enterocele or prolapse) the slings maybe any of a wide variety of shapes. As an example, the sling may be ofthe general shape of the slings described and shown in Moir et al., TheGauze-Hammock Operation, Journal of Obstetrics and Gynaecology of theBritish Commonwealth, Volume 75, No. 1, Pps. 1-9 (1968).

[0058] Suitable non-synthetic materials include allografts, homografts,heterografts, autologous tissues, cadaveric fascia and fascia lata.

[0059] Suitably synthetic materials for a sling include polymerics, andplastics and any combination of such materials may also be used in a kitof the present invention. Commercial examples of such materials includeMarlex™, Prolene™, and Vaskutek™. Other examples of suitable materialsinclude those disclosed in U.S. patent application Ser. No. 09/939,098filed Aug. 24, 2001 (the entire contents of which are hereinincorporated by reference). Specific examples of synthetic slingmaterials include, but are not limited to polypropylene, polyethylene,nylon, PLLA and PGA.

[0060] The sling material may be resorbable, absorbable ornon-absorbable. Optionally portions may be absorbable and other portionsmay be non-absorbable.

[0061] In one aspect of the invention, the sling 42 may comprise a meshmaterial. The mesh material comprises one or more woven, knitted orinter-linked filaments or fibers that form multiple fiber junctionsthroughout the mesh. The fiber junctions may be formed via weaving,knitting, braiding, bonding, ultrasonic welding or other junctionforming techniques, including combinations thereof. In addition, thesize of the resultant openings or pores of the mesh may be sufficient toallow tissue in-growth and fixation within surrounding tissue. As anexample, not intended to be limiting, the holes may comprise polygonalshaped holes with diagonals of 0.132 inches and 0.076 inches. Holes muchsmaller than this are not preferred as they may facilitate bacterialcolonization.

[0062] The quantity and type of fiber junctions, fiber weave, pattern,and material type influence various sling properties or characteristics.Non-mesh sling configurations are also included within the scope of theinvention. As another example, not intended to be limiting, the mesh maybe woven polypropylene monofilament, knitted with a warp tricot. Thestitch count may be 27.5 courses/inch (+ or −2 courses ) and 13wales/inch (+ or −2 wales). The thickness of this example is 0.024inches.

[0063] In another embodiment the sling material may have one or moresubstances associated therewith through a process such as coating.Examples of appropriate substances include, without limitation, drugs,hormones, antibiotics, antimicrobial substances, dyes, siliconeelastomers, polyurethanes, radiopaque filaments or substances,anti-bacterial substances, chemicals or agents, including anycombinations thereof. The substances may be used to enhance treatmenteffects, reduce potential sling rejection by the body, reduce thechances of tissue erosion, enhance visualization, indicate proper slingorientation, resist infection or other effects. For example, the slingmay be coated by the process described in U.S. Pat. Nos. 5,624,704;5,756,145; 5,853,745; 5,902,283 and 6,162,487 (the entire contents ofwhich are hereby incorporated by reference).

[0064]FIG. 1 illustrates a sling assembly comprising sling 42 and sheath44 that are made of biocompatible materials having sufficient strengthand structural integrity to withstand the various forces exerted uponthese components during an implant procedure and/or followingimplantation within a patient.

[0065] Preferably, the overall dimensions of the sling assembly 46,including insertion sheath 44 and sling 42 are sufficient to extend froman abdominal incision, to an undersurface of the urethra and back toanother abdominal incision with additional size to account for theimprecision associated with the range of human anatomy sizes. In apreferred embodiment, the sheath length of the assembly of the presentinvention is approximately within the range of 52.0 cm to 58.5 cm (20.5inches to 23.0 inches), sheath width is approximately within the rangeof 1.0 cm to 1.63 cm (0.482 inch to 0.642 inch) and sheath materialthickness is approximately within the range of 0.127 mm to 0.203 mm(0.005 inch to 0.008 inch), respectively. The associated sling 42 has alength, width and thickness approximately within the range of 40 cm to51 cm (15.7 inches to 20.1 inches), 1.0 cm to 1.2 cm (0.394 inch to0.472 inch) and 0.508 mm to 0.711 mm (0.020 inch to 0.028 inch),respectively.

[0066] The sling 42 of the present invention can be implanted withoutthe need for bone screws. Upon implantation, a portion of the sling 42is passed and/or woven through various layers of abdominal/pelvictissue.

[0067] The sling 42 is designed to remain within the body of a patientas an implant for a predetermined therapeutically effective amount oftime. The sling may be non-absorbable, absorbable or resorbable,including any combinations of these material properties, depending onthe desired treatment. The general characteristics of the sling materialand design should be such as to withstand the various forces exertedupon it during implantation (for example, frictional forces associatedwith tissue resistance) and after implantation (for example, increasedabdominal or bladder pressure caused by a stress event).

[0068] The precise, final location of the sling 42 will depend on avariety of factors including the particular surgical procedure(s)performed, and any preconditions of the patient such as scar tissue orprevious surgeries. For example, it may be preferred to place the sling42 in close proximity to, but not in contact with, a mid portion of theurethra to treat incontinence.

[0069] According to one embodiment, the sling may include a protectivesheath 44 (see FIG. 1). The sheath 44 is used during insertion of thestrip 42. After the sling 42 is implanted, the sheath 44 is removed anddiscarded. Preferably, the protective sheath 44 is constructed of amaterial that affords visual examination of the implantable slingmaterial 42 and that affords convenient passage of the assembly 46through tissue of the patient.

[0070] In a preferred embodiment, the sheath 44 is made of polyethylene.Other materials including, without limitation, polypropylene, nylon,polyester or Teflon may also be used to construct the sheath 44. Thesheath material should be flexible and provide sufficient structuralintegrity to withstand the various forces exerted on the sheath 44throughout the sling delivery procedure. In general, the sheath 44 isconfigured to have sufficient flexibility to facilitate usermanipulation and adequate structural strength to withstand the variousforces applied to the sheath 44 during delivery and/or positioning ofthe sling assembly 46. It should also conveniently separate from thesling material 42 after the sling 42 is implanted without materiallychanging the position of the sling 42.

[0071] The sheath 44 may comprise two elongate, separable sections.Optionally, portions of the sheath 44 may detachably and telescopicallyoverlap near the middle portion of the sling. In addition to resistingsling exposure and contamination, the overlapping section may also beused as a visual indicator for the practitioner or user of the device.Additionally, orientation indicia (not shown) may be placed on theoverlapping portion to indicate proper orientation of the sling relativeto the urethra. Alternatively, other configurations of the sheath 44 arewithin the scope of the present invention. In particular, the sheath maybe unitary as opposed to telescoping with perforations, slits, holes,scores or tear lines designed to allow separation and removal of thesheath 44.

[0072] During sheath removal, the first section and the second sectionof the sheath are slid off the sling 42 by pulling each end of thesheath 44 away from the middle portion of the sling assembly 46. Removalof the sheath 44 causes separation of the overlapping sheath sections,thereby exposing the sling 42. In addition, the smooth outer surface ofthe sheath 44 provides a relatively frictionless surface to facilitatepassage of the sheath 44 through the various tissues. The relativelyfrictionless motion also avoids disturbing the position of the sling 42relative to the anatomy of the patient.

[0073] In another embodiment of the invention, the sheath 44, or aportion thereof, is associated with one or more substances includingthose substances identified with respect to sling 42. The substances maybe used to enhance sheath removal, identify twists along the sheath 44(and thereby indicate proper sling orientation), indicatecutting/separation points, indicate center-point, resist infection orprovide other desirable effects. For example, a first surface of thesheath 44 may include indicia that should lie opposite the urethra orbladder neck to ensure proper sling orientation. Thus, the indiciaprovide the practitioner/surgeon with a visual indicator to aid inproperly orienting the sling assembly 46, and ultimately the sling 42,within the patient.

[0074] In another aspect, the present invention comprises a coupler(e.g. 54, FIG. 1) for use in a surgical sling procedure. Referring toFIGS. 2 through 8, the coupler 54 comprises a body portion having firstend portion 56 and second end portion 52 opposite the first end portion56. The first end portion 56 has surfaces for receiving the insertionend of a needle (e.g. end 58 of needle 60). The coupler also includes aninternal passageway with structure for connecting the needle 60 to thecoupler 54.

[0075] Referring to FIG. 16, the coupler 54 is attached to the insertionend 58 of needle 60 after the end 58 emerges from a vaginal incision404. The connection between the needle 60 and the coupler 58 isaccomplished quickly by pushing the coupler onto the end of the needlein a substantially axial fashion. As used herein, when it is said thatthe needle and coupler are moved together in a substantially axialfashion, it is meant that the motion is substantially linear with slightcurvatures being with the scope of the invention. Preferably, the motionis substantially parallel with the axis of the coupler, taking intoaccount that the coupler and/or needle may have a slightly curved axis.Connecting the needle and coupler in a substantially axial fashion, asopposed to articles that connect by being screwed together, is believedto be less distracting and more convenient for a surgeon. This motion isalso believed to be less likely to cause the needle to deflect anddamage tissue.

[0076] The force required to connect the coupler 54 to the needle 60should be relatively small to avoid distracting the surgeon. Byrelatively small, it is meant that the force required to connect theneedle and coupler should not unduly tax the strength of a majority ofpeople.

[0077] Preferably, there is a tactile sensation when the coupler 54 isfully seated on the needle 60. The tactile sensation signals the surgeonthat the needle 60 may be pulled upward through the body withoutseparating from the coupler 54.

[0078] The second end portion 52 of the coupler 54 has sling associationstructure for associating the article with a sling or another needle(see FIG. 21). The sling association structure may comprise a hole 90and a portion of internal passageway 96 near end 52.

[0079] Preferably, the coupler 54 comprises a dilator that dilates atrack for ease of sling introduction and positioning within the patient.End 58 of the needle 60 is preferably keyed to allow for convenient,secure attachment of the needle 60 relative to the coupler 54. In apreferred embodiment, the key feature resists rotation of the coupler 54relative to the needle 60.

[0080] The assembly preferably includes two couplers. The coupler 54atraumatically creates and/or expands the passageway through the tissuesfor sling assembly delivery. The coupler 54 is preferably short relativeto a needle 60 for ease of passage of the assembly and to reduce theoverall amount of tissue that is deflected at one time. Preferably, thecoupler is less than 2.5 inches in length, and more preferably, it isless than 1.5 inches in length. The maximum radius of a coupler 54 ispreferably less than 10 mm, more preferably less than 7.5 mm, even morepreferably less than 5 mm. The tip of the coupler 54 is preferablyblunt, as, in preferred embodiments, the leading tip of the coupler 54will pass through tissue that has already been pierced by a needle 60.

[0081] The coupler 54 may be made from a variety of biocompatible andsterilizable materials including, without limitation, acetal,polypropylene, Delrin®, Acrylonitrile-Butadiene-Styrene (ABS),polyethylene, nylon and any combination of biocompatible materials.

[0082] The coupler 54 preferably includes internal surfaces shaped in apredetermined fashion to engage or abut complementary surfaces on needle60. In a preferred embodiment, the needle connector surfaces afford apermanent affixation between the coupler 54 and the needle 60. By“permanent affixation”, it is meant that it would be very difficult toseparate the coupler from the needle after they have become permanentlyaffixed.

[0083] After implantation of the sling 42, to separate the sling 42 fromthe coupler 54/needle 60, the surgeon cuts an end of the sling 42 asdescribed more fully below. The needle/coupler attachment surfacespreferably afford quick and convenient attachment of the coupler 54 tothe needle 60 to avoid wasting time in the midst of a surgicalprocedure. In contrast to focusing on a tedious or difficult connectionof an article protruding from the body and another article, with thepresent invention, the surgeon can rapidly and securely attach theneedle 60 to coupler 54 simply by pushing the coupler 54 onto the needle60 in a substantially axial (preferably linear) fashion. The attachmentis secure to avoid separation of the needle 60 and coupler 54 while thecombination is passed through tissue.

[0084] As seen in FIGS. 1 through 9, the first and second ends 58 and 62of the needle 60 may include a keying feature affording secureassociation between the needle and coupler 54 and/or sheath assembly 46.In one embodiment, the keying feature comprises a recess 130 and/orsquare-shaped portion 126. As previously described, the recess 130 andsquare-shaped portion 126 are designed for complementary engagement tothe appropriate end of coupler 54.

[0085] The coupler 54 also includes a universal sling associationstructure (e.g. hole 90) for associating with a sling. Preferably, thecoupler 54 is preattached to the sling 42 and/or sheath 44 (or thecombination thereof), particularly if the sling is a synthetic material.

[0086] Referring to the embodiment of coupler shown in FIGS. 2 through8, the coupler 54 maybe approximately 3.1 cm (1.2 inches) in length. Thecoupler 54 preferably includes a gentle taper 88 near its first end 56.The coupler is sized and shaped to provide atraumatic passage throughbody tissue. The taper 88 and relatively smooth outer surface of thecoupler 54 facilitate atraumatic passage of the coupler 54 and attachedsling assembly 46 through the various tissues of the patient. Thepresence of the coupler 54 preferably allows a gentle transition betweenthe diameter of the needle, to the shape of the coupler, and finally tothe sling assembly 46, as opposed to prior art assemblies, where thestructure of the sling assembly abruptly increases the profile of theneedle and thereby the size of the structure that must pass throughtissue.

[0087] Preferably, the second end 52 of the coupler 54 associates thecoupler with one end of a sling 42, or sheath 44 or sling assembly 46.The sheath 44 or sling 42 is preferably attached to the coupler 54 via afirst opening or through-hole 90 located near the second end of thecoupler 54. In this embodiment, the opening 90 could receive a varietyof materials, such as fascia, autologous materials, synthetics, biologictissues and any other similar tissues, including any combinations.

[0088] In the embodiment shown in FIG. 1, the end portion 48 or 50 ofone end of the sheath 44 is threaded through the opening 90 of thecoupler 54 and secured to the sheath 44, thereby forming a loop. Theedge portion 48 or 50 may be fastened onto the sheath 44 via ultrasonicwelding, bonding, melting, suturing, sealing or other attachmenttechniques. Further, as shown in FIG. 2, the end 52 of the coupler 54preferably includes a cut-away section 94 to provide room to receivesling assembly material to reduce the overall profile of the slingassembly experienced by tissue during sling passage. Therefore, when thesheath is attached to the cut-away section, the additional sheathmaterial is not apt to significantly increase the relative thickness,diameter or profile of the coupler 54.

[0089] Alternatively, for couplers 54 manufactured via some moldingtechniques, the end of the sheath 44 may be encased within and securedto the second end 52 of the coupler 54 during the molding process. Inyet another embodiment, the end of the sheath 44 may be fixedly attachedwithin a longitudinal slot located near the first end 52 of the coupler44 using an adhesive, ultrasonic welding or other attachment techniques.

[0090] Referring to FIGS. 2-6, the first end 56 of the coupler 54includes a second opening or through-hole or lumen 96 that extendssubstantially internally along the longitudinal axis of the coupler 54.The hole 96 preferably extends the length of the coupler 54.

[0091] The lumen 96 has an internal diameter generally configured forconvenient attachment to a needle 60 or similar sling-delivery device.In one embodiment, the internal diameter of the second opening 96 of thecoupler 54 is approximately within the range of 0.239 cm to 0.318 cm(0.094 inch to 0.125 inch). A shoulder 98 located on the surface 100 ofthe second opening 96 of the coupler 54 and a complementary matingrecess located on the surface of the first end of the needle 60 securelyand permanently attach or lock the coupler 54 and needle 60 together.Once the needle 60 is inserted into the coupler 54, they are preferablynot separated thereafter. After the sling 42 is implanted, the connectedneedle 60 and coupler 54 are removed from the sling by cutting an end ofthe sling as described in greater detail below. Preferable, the needle60 and coupler 54 are discarded after the surgical procedure.

[0092] One or more longitudinal slots 102 located on the outer surfaceof the coupler 54 and in communication with the second opening 96 allowthe wall of the coupler 54 to expand in a radially outward directionwhen the first end of the needle 60 is inserted into the second opening96 of the coupler 54. When the shoulder 98 of the coupler 54 passes therecess of the needle 60, the wall of the coupler 54 collapses around theneedle 60 as the shoulder 98 seats into the recess, thereby securing thecoupler 54 on the needle 60 and blocking separation of the coupler 54and needle 60.

[0093] Although the invention has been described in terms of a shoulder98 and mating recess, alternative coupler-needle attachment mechanismssuch as bumps, grooves, slots, wedges, detents and other mechanisms arealso included within the scope of the claimed invention.

[0094] The coupler 54 preferably includes one or more relief ports 104to facilitate convenient needle connection. The relief ports 104 may beformed at the ends of the longitudinal slots 102 or at varioushigh-resistance locations along the coupler 54. The relief ports 104decrease the rigidity or resistance of radially outward expansion of thecoupler wall and reduce the amount of force required to insert orsecurely attach the needle 60 to the coupler 54. The relief portscontribute to a desired reduction in the force required to insert theneedle into the coupler 54. In yet another embodiment, superficial bandsor rings, arc-shaped slots, superficial grooves or other mechanisms mayprovide improved expansion or attachment characteristics.

[0095] A portion of the coupler 54 includes a taper 88 having adecreasing profile toward the second end 56 of the coupler 54. The taper88 preferably gently cams tissue out of the path of the sling assembly46 as the sling assembly is inserted in the body. The taper 88 is alsosized and shaped to reduce the amount of friction or resistance as thedevice is drawn through the tissues of the patient. The amount of forcerequired to manipulate the device through the tissues is therebyreduced. This in turn provides the user of the assembly with additionalcontrol over device insertion and maneuverability through tissue andwithin the patient. In addition to tapered profiles, other couplerprofiles such as conical, flared, frusto-conical, pyramid-shaped,elliptical or other applicable profiles may also be used. Overall, theprofile of the coupler 54 is preferably configured to provide easydilation of the tissue to accommodate smooth passage of the sling42/sling assembly 46 and subsequent collapse of the surrounding tissueto securely anchor the sling 42 into the tissue (after sheath removal).

[0096] The assembly of the present invention optionally includes handles64. The handles may have any of the structure and features described inU.S. patent application Ser. No. 09/917,443 filed Jul. 27, 2001 (theentire contents of which are herein incorporated by reference).

[0097] Instead of a hole 90 in the coupler 54, another mechanism may beutilized to connect a coupler 54 to a surgical sling material, sheath orsling assembly.

[0098] Other accessories may also optionally be included in a kitaccording to the present invention. For example, a surgical drapespecifically designed for urological procedures such as a slingprocedure may be included in a kit of the present invention. Such adrape is disclosed in U.S. patent application Ser. No. 09/749,254, filedDec. 27, 2001 (the entire contents incorporated herein by reference).Alternatively, an article for objectively setting tension of the device,such as those described in U.S. application Ser. No. 09/968,239, filedOct. 1, 2001 (the entire contents of which are incorporated byreference) may be included in the kit.

[0099] The kits according to the present invention preferably include atleast two needles. Two or more needles reduce the need to reuse a needleat a different location with a patient, thereby eliminating crosscontamination issues. Additional needles, handles, couplers and otherelements may also be included for surgical convenience, for avoidance ofcontamination from one portion of the body to another, for ease ofmanufacturing or sterilization or for surgical requirements.

[0100] The individual elements of the kits of the present invention maybe packaged together, separately or in subassemblies depending on avariety of factors such as shelf life and sterilization requirements.They may be assembled at the manufacturing location or at the healthcarelocation. Any suitable sterilization procedure may be utilized tosterilize the contents of a kit. Suitable sterilization techniquesinclude, but are not limited to steam, ethylene oxide, electron beam,vapor (e.g. hydrogen peroxide or peracetic acid), or plasma procedures.

EXAMPLE 1

[0101] Needle/Coupler

[0102] A needle as shown in FIGS. 9 and 10 was constructed from 316stainless steel. A coupler as shown in FIGS. 2 through 6 and 8 wasinjection molded from acetal (Texapol 5209). Table A lists some of themeasurements of the various features. TABLE A Reference Character inFIGURES Length (inches) D 1.195 Y .031 C .235 A .139 Z .085 X .096 B.230 L .645 N 8.680 O .515 P 0.25 Q 0.13 R .094 S .060

[0103] Various additional construction details of the coupler and needleare disclosed in U.S. Provisional Patent Application Attorney Docket No.AMS-032P, filed Nov. 20, 2001, entitled, “Sling Assembly Articles”,Inventors: Gary Rochleau, Johann (Hans) Neisz and Gary Nachreiner (theentire contents of which are expressly incorporated by referenceherein).

EXAMPLE 2

[0104] Insertion/Separation Force

[0105]FIGS. 10 and 11 are schematic illustrations of test equipment usedto record Separation Forces and Insertion Forces for a needle andcouplers. Ten sterilized and aged couplers were provided in accordancewith Example 1. A new coupler was used for each InsertionForce/Separation Force test. A single needle was constructed inaccordance with Example 1. The needle was used for each InsertionForce/Separation Force test.

[0106] The test equipment included an Instron, 200 lb Load cell, TorqueMeter device. To obtain the Insertion Force, the needle was loaded intothe load cell in the Instron device. The coupler was loaded into aholding fixture (see FIG. 11). The fixture was clamped into the lowerair grip of the Instron device. The needle was lowered down and insertedinto the coupler to align the needle and coupler but not to induce aload. The needle was then inserted substantially in the direction of thearrow in FIG. 11 at a rate of 0.5 in/sec into the coupler until itlocked onto the coupler. The Insertion Force was then recorded.

[0107] To obtain the Separation Force measurement, the needle was pulledout of the coupler in the direction of the arrow in FIG. 12 at a rate of0.5 in/sec. The Separation Force was then recorded.

[0108] The data for the Separation Force and the Insertion Force isrecorded in Table B. TABLE B Needle/Coupler Needle/Coupler InsertionForce (lbs.) Separation Force (lbs.) 7.95 33.50 7.74 31.74 5.28 35.596.89 32.33 5.32 29.57 9.53 30.82 6.17 30.93 8.86 30.86 7.58 34.40 6.9629.52

[0109] An analysis of the data of Table B is provided in Table C. TABLEC Needle Coupler Insertion Needle Coupler Separation Force (lbs.) Force(lbs.) Average 7.229 31.926 Standard 1.400 2.025 Minimum 5.278 29.520Maximum 9.530 35.590

[0110] The results show that the Insertion Force is sufficiently low tomake the needle/coupler attachment easy and convenient for almost everyuser, regardless of the individual's strength. Additionally, theseparation force is extremely high to resist undesired separation of thecoupler and needle.

[0111] A cadaver study was also conducted to study the force required topull a coupler through tissue. This was determined using a Chatillonforce measurement device on a needle assembly and pulling the couplerthrough tissue. In this test, the force on the coupler was found to be11 lbs. Additional tests in animal tissues supported the belief that theforce on the coupler as it moves through tissue is between about 3 andabout 12 pounds. As a result, the Separation Force of this example iswithin desired limits.

[0112] Examples of Surgical Procedures

[0113] Several methods are contemplated herein. Procedures that addressproblems other than incontinence (e.g. cystocele, enterocele orprolapse) are also contemplated alone or in conjunction with the presentinvention. Further, the term “urethra,” with respect to slingpositioning, is used for brevity and reader convenience. It should benoted that the present invention is particularly suitable for placing asling in a therapeutically effective position. The method may beutilized to support a variety of structures at different anatomicallocations. As such, the terms “target site,” “bladder”, “urethro-vesicaljuncture”, “vaginal vault”, “U-V juncture” and “bladder neck” are alsoincluded within the scope of the present invention.

[0114] The present invention includes surgical procedures that utilizethe novel surgical instruments and articles described above. The presentinvention also includes improved surgical sling procedures.

[0115] The present invention preferably utilizes a suprapubic approach,at least initially. A suprapubic approach affords greater control overthe end of a needle to avoid areas with sensitive vascular structuresand the obturator nerves. Further the heightened control associated witha caudad passage is believed to avoid injury to bowel tissue.

[0116] Referring now to FIGS. 13 through 20, a preferred embodiment ofsurgical procedure is disclosed. Initially, the patient is placed underlocal, spinal or general anesthesia. A small transverse incision 404 ismade in the anterior vaginal wall 20 of a female patient followed by atransurethral dissection. Two small transverse suprapubic abdominal stabincisions 400 are also made near the back of the pubic bone (e.g. eachabout 1 cm from the midline, or alternatively, one large incision may bemade) to allow for needle entry. Optionally, two paraurethraldissections (incisions next to the urethra) lateral to the midline maybe created to allow the surgeon's finger to meet the end 58 of theneedle 60 during the procedure.

[0117] A handle 64 may optionally be used. Alternatively, the needle 60can be used alone, without the handle 64. FIG. 13 shows the end 58 ofneedle 60 just passing an abdominal incision 400. Preferably, after theend 58 of the needle 60 passes the suprapubic abdominal incision 400,the surgeon seeks to encounter resistance associated with the posteriorportion of the patient's pubic bone 402 with the end 58 of the needle 60to controllably move the end 58 of the needle toward the vaginalincision 404 and to help avoid damaging structures such as the urethraand bladder of the patient. The end 58 of the needle 60 is used toidentify the location of the pubic bone 402. The surgeon exploits theresistance provided by the pubic bone 402 to controllably pass the endof the needle 58. This approach is preferred as it helps keep the needle60 away from major pelvic vessels, nerves and anatomical structures suchas the urethra, bowels and bladder.

[0118]FIG. 14 illustrates the end of the needle as it just passes thesuprapubic incision. FIG. 15 illustrates the needle 60 as the surgeonbegins to experience the tactile feel of the resistance provided in partby the posterior portion of the pubic bone 402. FIG. 15 shows the needle60 as it passes in proximity to the posterior surface of the pubic bone402 which continues to operate as an anatomical guide for the surgeon asthe needle end 58 approaches vaginal incision 404 (see FIG. 16).

[0119]FIG. 16 illustrates the needle as it passes out of a vaginalincision 404. Optionally, with the index finger of a hand, the surgeonmay meet the end 58 of the needle via the paraurethral dissection. Thesurgeon's finger may be delicately placed adjacent endopelvic fascia ofthe patient and used to guide the needle 60 through the relatively toughendopelvic fascia and into the vaginal incision 404. This helps thesurgeon keep away from structures such as the bladder, urethra and othersensitive tissue.

[0120] The small diameter and curvature of the needles 60 help toprovide precise passage of the needles 60 to the vaginal incision 404.In addition, this needle configuration creates a minimally invasivepathway through tissue extending between the abdominal wall and pubicspace, thereby reducing the risk of perforating the bowel and/or bloodvessels and nerves located lateral to the bladder 14.

[0121] The steps described above are preferably repeated as needed for asecond needle 60 on the other side of the urethra 16. Once both needlesare placed, surgeons typically perform a cystoscopy to ensure that thebladder is not punctured before implanting the sling. A cystoscopyconfirms the integrity of the bladder 14 and urethra 16 or recognizes abladder perforation.

[0122]FIG. 17 is a perspective view of a sling associated with twoneedles 60. Adapters (e.g. couplers 54) are pushed onto the ends 58 ofneedles 60 as shown in FIG. 17. The couplers 54 are preferably snappedirreversibly into place for a secure connection. Next, if a syntheticsling assembly (such as the sling assembly of FIG. 1) is used, theplastic sheath 44 is oriented so that the optional center orientationindicia (e.g. a blue mark) is facing away from the surgical field,toward the surgeon

[0123] After the couplers 54 are attached to the needles 60, the slingassembly 46 is properly oriented so that the sling assembly 46 is nottwisted when attached to the couplers 54. Once the couplers 54 aresecurely attached, the needles are pulled up through the suprapubicincisions, taking care to avoid contact with sensitive tissue. The slingis then clamped with surgical clamps (not shown). During this portion ofthe process, the attached couplers 54 and sling assembly 46 areatraumatically pulled up through the needle paths, advancing the slingassembly 46 adjacent to and looped beneath the urethra 16 or targetsite. A portion of each end of the sling assembly 46 extending beyondthe suprapubic incisions 400 is clamped and then cut to release theneedles 60 and attached couplers 54.

[0124] The sling is placed in a therapeutically effective position. Theprecise anatomical position will depend upon a variety of factorsincluding the type and degree of anatomical damage or insufficiency,whether the sling procedure is combined with other procedures and othersurgeon decisions. Typically, the sling is placed midurethra, withouttension, but in position to support the midurethra. Alternatively, thesling could be placed to support the bladder neck and/or UV junction.

[0125] Once the sling assembly 46 is carefully positioned under themidurethra or target site to provide sufficient support to the targetsite, the overlapping portion of the sheath 44 located near the centerof the sling assembly 46 and optional member 66 (i.e. tensioningfilament) may then be used to center and properly position the slingassembly 46 under the midurethra. The sheath 44 is then removed.

[0126]FIG. 18 shows the sling being tightened during the surgicalprocedure. Sling tension may be tightened by placing a device, such as aclamp, across one or both ends of the sling 42, suprapubically.Generally, the surgeon grasps the mesh adjacent the suprapubic incision400 and pulls upward to increase the degree of tightness of the mesh.FIG. 18 shows the sling after the couplers have been cut off, but priorto final trimming.

[0127] After the couplers 54 are trimmed off, the plastic sheath 44 isremoved from the sling mesh 42 by pulling up on both sides of the sheath44, preferably one at a time. Optionally, to avoid overtightening thesling mesh 42 while removing the sheath 44, a forceps or other bluntinstrument may be placed between the sling and the urethra. The forcepsor other blunt instrument may be used to help establish a tension freeaspect of the sling.

[0128] In another embodiment of the invention, shown with reference toFIG. 21, a method includes the steps of: providing at least onesuprapubic or abdominal needle 602 with a relatively small diameter(e.g. less than 4 mm), and at least one sling associated needle 604, asling 610 attached to the sling associated needle 604, and an adapter(e.g. coupler 54) having sling associated needle receiving surfaces(e.g. an end of innerpassageway 96 near the end of the coupler havinghole 90) for receiving the end of the sling associated needle 604. Forexample, the sling associated needle 604 and sling 610 may comprise aTVT needle and sling available from Ethicon of New Jersey.

[0129] The method includes the steps of creating at least one vaginalincision 404, creating at least one suprapubic incision 400, andinitially passing the suprapubic needle 602 through the suprapubicincision 400 and then through the vaginal incision 404, and connectingthe adapter 54 to the needle 602 in a substantially axial fashion.

[0130] After being attached to a coupler, needles 604 are initiallypassed through vaginal incision 404 and toward one of the suprapubicincisions 400. While inserting the needles 604 initially through thevagina is not preferred, it is within the scope of the presentinvention, as some surgeons may prefer this approach due to previoussurgical training, custom or personal preference. The method includesthe step of placing the end of the sling associated needle 604 in an endof the coupler 54, and then moving the sling associated needle 604 fromthe vaginal incision 404 to the suprapubic incision 400 with at leastthe guidance of the suprapubic needle 602 to implant the sling 610.Handle 620 may be connected to a sling attachment end of needle 604 forthis purpose. Guiding the end of the large sling associated needle 604in this fashion is believed to help avoid contact between the sharp tipof needle 604 and sensitive structures such as obturator nerves, andvascular structures such as the superficial epigastric vessel, theinferior epigastric vessel, the external iliac artery and the obturator.Optionally, the coupler and sling associated needle 604 may includecomplementary engagement surfaces for securely attaching the needle 604to the coupler 54 (and hence to the needle 602).

[0131] Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. An assembly for treating incontinence comprising:an elongate needle that is sized and shaped to be initially insertedthrough an abdominal incision and to then emerge from a vaginalincision, the needle having an insertion end and an end opposite theinsertion end, a sling for implantation in the body during anincontinence procedure, and a coupler having an axis, the coupler havinga first end and a second end with surfaces for conveniently and securelyconnecting the coupler to the insertion end of the needle by moving thecoupler and insertion end of the needle together.
 2. An assemblyaccording to claim 1, wherein after the needle is connected to thecoupler, the assembly has a Separation Force of at least about fifteenpounds.
 3. An assembly according to claim 2, wherein after the needle isconnected to the coupler, the assembly has a Separation Force of atleast about thirty pounds.
 4. An assembly according to claim 2 wherein,the assembly has an Insertion Force of no more than about fifteenpounds.
 5. An assembly according to claim 4 wherein, the assembly has anInsertion Force of no more than about ten pounds.
 6. An assemblyaccording to claim 5 wherein, the assembly has an Insertion Force of nomore than about eight pounds.
 7. An assembly according to claim 1wherein the coupler is sized and shaped to be connected to the needleafter the insertion end of the needle emerges from the vaginal incision.8. An assembly according to claim 1 wherein the sling includes aninsertion sheath and the first end of the coupler is attached to thesheath.
 9. An assembly according to claim 1 wherein the tip of theinsertion end of the needle is substantially blunt.
 10. A coupler foruse in an incontinence procedure that utilizes a sling and an elongateneedle that is sized and shaped to be initially inserted through anabdominal incision and to then emerge from a vaginal incision, theneedle having an insertion end, the coupler comprising: an elongate bodyhaving an axis, a first end and a second end, and surfaces forconveniently and securely connecting the coupler to the insertion end ofthe needle by moving the second end of the coupler and the insertion endof the needle together in a substantially axial fashion; wherein afterthe needle is connected to the coupler, the connected coupler and needlehave a Separation Force of at least about fifteen pounds.
 11. A methodof treating incontinence in a female patient comprising the steps of:providing a first needle that is sized and shaped to be initiallyinserted through an abdominal incision and to then emerge from a vaginalincision, the needle having an insertion end and an end opposite theinsertion end, providing a coupler having an axis, the coupler having afirst end and a second end with surfaces for conveniently and securelyconnecting the coupler to the insertion end of the needle, providing asecond needle that is sized and shaped to be initially inserted througha vaginal incision and to then emerge from an abdominal incision; thesecond needle being attached to a synthetic surgical mesh having firstand second ends and a plurality of holes that are sized and shaped toafford tissue ingrowth, and a removable synthetic insertion sheathassociated with the surgical mesh, creating at least one vaginalincision, creating at least one abdominal incision, initially passingthe first needle through the abdominal incision and then through thevaginal incision, connecting the second end of the coupler to theinsertion end of the first needle, connecting the first end of thecoupler to the second needle; and guiding the second needle from thevaginal incision to the abdominal incision with the first needle toimplant the sling.